Satellite V (COVID-19 coronavirus vaccine)

Main questionnaires:

• COVID-19 coronavirus vaccine
• Vaccines against coronavirus COVID-19 in Russia

Sputnik V is the Russian, the world's first registered vaccine based on the human adenovirus vector. Vectors are carriers that can deliver genetic material into a cell. At the same time, the genetic code of the adenovirus that causes the infection is removed and material with a protein code from another virus, in this case from the spike of the coronavirus, is inserted in its place. This new element is safe for the body, it helps the immune system to produce antibodies that protect against infection.

The vector virus can only be grown in living cell cultures, which is required when scaling high-tech production. And with this there may be difficulties in some countries. The vaccine must be stored at minus 18 degrees, making logistics difficult. It should be noted that Sputnik V is produced in two forms - frozen and dried. Dried simplifies logistics.

Satellite light

• Satellite light

Satellite V (internasal form)

• Satellite V (internasal form)

Sputnik M

Main article: Sputnik M

2023

Hackers posted "classified" documents about the vaccine on the Internet

In mid-March 2023, it became known that cybercriminals posted hundreds of documents on the Internet related to the development and clinical trials of the Sputnik V vaccine for the prevention of coronavirus infection COVID-19.

According to Cybernews, the cyber group known as KelvinSecurity announced the disclosure of confidential information. It is alleged that the data were obtained as a result of "checking the mailboxes of the developer company" - the N. F. Gamaleya National Research Center for Epidemiology and Microbiology. In other words, we are talking about hacking the IT systems of this organization.

Our mission was to see and demonstrate that the vaccine is ineffective and that this is just Russian state propaganda, Cybernews quotes statements by members of the KelvinSecurity group.

As reported, the documents, among other things, contain information about the death of participants in clinical trials of the Sputnik V vaccine (registration name Gam-COVID-Vac), including the names of the victims. Fatalities are allegedly recorded in countries such as Ghana and Egypt. Hackers claim that some documents were classified: they provide information about the stages of vaccine development, funding and quality. Some files include technical details, while others relate to negotiations with foreign companies, including those from Switzerland. In total, more than 300 files with a total volume of approximately 522 MB have been posted on the Internet.

Other documents contain invoices and relate to the cost of scientific work, one of which is estimated at seven million rubles, or about 93,000 dollars. There is also information about the various laboratories that produced the vaccine and the level of their performance, Cybernews reports.[1]

One of the creators of the Sputnik V vaccine was killed in Moscow

On March 3, 2023, it became known about the murder of Andrei Botikov, a senior researcher at the N.F. Gamaleya National Research Center for Epidemiology and Microbiology. This was reported by TASS and RIA Novosti, citing its sources in law enforcement agencies. Read more here.

Joining the number of leaders among vaccines against coronavirus in the number of vaccinated in the world

The Russian Sputnik V coronavirus vaccine has become one of the leaders among other drugs against COVID-19 in terms of the number of vaccinated on a global scale. This was announced in early February 2023 by the Russian Direct Investment Fund (RDIF). Read more here.

2022

Russia exported a vaccine worth $1.3 billion

The Sputnik V vaccine is the most exported drug in the history of Russia. This was announced in mid-October 2022 on the air of the Russia 24 TV channel by the general director of the Russian Direct Investment Fund Kirill Dmitriyev.

{{quote 'Of course, Sputnik has become the most exported drug in the history of Russia. RDIF created such a virtual pharmaceutical company in just a few months and managed to sell Sputnik for export by more than $1.3 billion, actually increasing the export of vaccine drugs by 20 times only through the export of Sputnik, - said Kirill Dmitriyev. }}

The Russian vaccine was registered in more than 70 countries. According to Dmitriyev, one of the main clinical trials of the drug was carried out in the United Arab Emirates.

{{quote 'This work was very important, because when the United Arab Emirates registered the vaccine, it became a sign of quality not only for the Middle East, but also for many countries in the world, he said. }} Dmitriyev stressed that thanks to the impressive results of clinical trials and real use, the national vaccine has proven its safety and effectiveness not only in Russia, but also in a large number of foreign countries.

In August 2022, it became known that the Center named after Gamaleya of the Ministry of Health of Russia has developed an adapted version of the Sputnik V vaccine against new variants of the delta and omicron coronavirus. At the same time, it was noted that the current version of the Sputnik V vaccine continues to demonstrate high effectiveness against hospitalization from the omicron strain (97%), as well as against critical cases when booster with Sputnik Light or revaccination (99.4%).^[2]

In Russia, they began to introduce Sputnik V through the nose for injection

In August 2022 Russia , Sputnik V was injected through the nose. Ministry of Health They explained that, according to the instructions, the introduction COVID-19 of this vaccine against coronavirus is possible both intramuscularly and internasally.

As noted by the Assistant Minister of Health of the Russian Federation Aleksei Kuznetsov, the Sputnik V vaccines in the forms of nasal drops and a solution for intramuscular administration are identical in composition.

In fact, from a medical point of view, using an internasally separate vaccine or a regular Sputnik V is the same thing. However, legally these are different drugs. According to regulatory rules, you can't just take a vaccine for intramuscular administration, open it, remove the protective cap, change it to a nozzle - and get a new drug, - said Nikolai Kryuchkov, an expert on the development and research of drugs, in a conversation with Businessman"."

According to the newspaper, in mid-August 2022, the head of the health committee of the Kursk region, Ekaterina Pismennaya, said that the region was the first in the Russian Federation to launch "mass nasal vaccination against coronavirus." She clarified that the nasal vaccine was admitted to all medical institutions and is popular: only in one of the large points in Kursk it is vaccinated about 100 people a day, and in total 6933 residents of the region have already been vaccinated. According to the head of the komzdrav, the nasal vaccine is more easily transferred than usual, no serious side effects were detected during its use.

The administration of the Kursk region told the publication that the region "took the initiative, independently contacted the supplier of nasal vaccine attachments, thus becoming one of the three constituent entities of the Russian Federation among the first to receive a nasal vaccine for mass vaccination of the population." The first batch of 12 thousand nozzles (atomizers) arrived in the region^[3]

Sputnik V has become the most exported drug in the history of Russia

August 11, 2022 marks exactly two years since the registration of Sputnik V, the world's first vaccine against the coronavirus COVID-19. Noting this date, the general director of the Russian Direct Investment Fund (RDIF) Kirill Dmitriyev said that Sputnik V has become the most exported drug in Russian history.

Vaccine... has rightfully established itself as one of the most effective and safe tools to combat coronavirus infection in the world. This is confirmed by the results of more than 50 clinical studies and data on the use of Sputnik V within the framework of national vaccination programs in various regions of the world, including Europe, Asia, the Middle East and Latin America, "Dmitriev said.

According to him, as part of the mass production of the drug, for the first time in history, the RDIF created an international network of production partners, and also localized the release of the Russian vaccine at 27 sites in 18 countries. Sputnik V was trusted in 71 countries of the world, where over 4 billion people live, said the head of the RDIF.

He also recalled that the vaccine helped protect people from the original strain of COVID-19, bring down the peak incidence, and also showed effectiveness in combating new mutations, including delta and omicron strains.

At the initiative of the RDIF, a one-component vaccine "satellite Light" was also developed, which is successfully used in more than 30 countries by August 2022. The fund initiated and funded joint research with other leading vaccine manufacturers to create vaccine cocktails with Sputnik Light, the RDIF CEO added. He stressed that the Russian one-component drug is a universal booster for other vaccines.

In conclusion, Dmitriyev noted that the pandemic should be an important lesson for all mankind. Unity and collective efforts are needed when it comes to saving lives.

Only this path makes it possible to effectively counter future threats, including of an epidemiological nature, "he said.[4]

Efficacy against hospitalization from the Omicron strain 97%

June 15, 2022 NICEM named after N.F. Gamalei announced the publication of the results of a study of the effectiveness of the Sputnik V vaccine against hospitalization from the Omikron strain (B.1.1.529), conducted by a team of scientists from the City Clinical Hospital No. 67 named after L.A. Vorokhobov and the Gamaleya Center. According to the results of the study, the effectiveness of the two-component Sputnik V vaccine against all types of hospitalizations from the Omicron strain is 97% with booster 3 and 4 doses (single-component Sputnik Light or repeated vaccination with Sputnik V).

According to a study involving more than 1,000 patients in Moscow from January 11 to February 21, 2022, the effectiveness of the Sputnik V vaccine among patients who were vaccinated with at least 1 dose was 85.9% against all types of hospitalizations.

When booster with the 3rd and 4th doses (Sputnik Light or Sputnik V revaccination), the effectiveness was:

• 97% against all types of hospitalization;
• 97.7% versus moderate to severe cases;
• 98.6% against severe and critical cases;
• 99.4% versus critical cases.

The study shows that vaccination with Sputnik V and Sputnik Light provides high effectiveness of protection against hospitalization in case of disease with the Omicron strain. The greatest effectiveness is shown when protecting against critical cases of the disease requiring hospitalization in the intensive care unit.

As of June 2022, Sputnik V is approved for use in 71 countries with a total population of more than 4 billion people, and the Sputnik Light vaccine in more than 30 countries. The Russian Direct Investment Fund (RDIF) has become an investor in the development and production of Sputnik V and Sputnik Light.

Ministry of Health of the Russian Federation: Sputnik V vaccinated 0.5 billion people

On June 9, 2022, the Ministry of Health of the Russian Federation spoke about vaccination against the coronavirus COVID-19 with the drug "Sputnik V" more than 0.5 billion people

The volume of supplies of the Sputnik V vaccine - more than 500 million people in the world received this vaccine. These are such colossal successes, - said the Minister of Health Mikhail Murashko in an interview with the Uzbekistan-24 TV channel.

According to Vedomosti on June 9, 2022, the effectiveness of Sputnik V against the Wuhan strain of coronavirus was 91%, against the delta strain - 70.5%, and against severe cases of COVID-19 - more than 88%, the website says стопкоронавирус.рф. According to the RDIF, Sputnik V was registered by about 70 countries, in which half of the world's population lives.

In April 2022, the nasal form of the Sputnik V coronavirus vaccine entered civilian circulation. Its composition does not differ from the usual form of the drug.

The nasal "Sputnik V" consists of two components and is inserted into the human nose using a special spray nozzle with an interval of three weeks. The drug forms mucosal immunity on the nasal mucosa, as well as humoral and cellular immunity in the blood. Contraindications to the use of the vaccine are severe allergic reactions, hypersensitivity to the components of the drug and acute diseases. With exacerbation of chronic diseases, you can be vaccinated two to four weeks after recovery or remission.

Also, by the beginning of June 2022, Russia is undergoing clinical trials of the second nasal vaccine against coronavirus by Generium. Earlier, the company bought a license to develop such a vaccine based on Sputnik V from the Gamaleya Scientific Center.^[5]

Phase II clinical studies to assess the safety of combined use in conjunction with the AstraZenecki vaccine

On February 14, 2022, the R-Pharm Group of Companies, the Russian Direct Investment Fund (RDIF, the sovereign fund of the Russian Federation) and AstraZeneca announced interim results of phase II clinical trials to assess the safety of the combined use of AstraZeneca vaccine and the first component of the Sputnik V coronavirus vaccine (Sputnik Light drug based on human adenovirus 26 serotype). Read more here.

Photophobia and osteoarthritis - new side effects of the vaccine

As it became known in early February 2022, the |Ministry of Health of the Russian Federation approved changes to the section "Side effects" of the Sputnik V instruction. Two new side effects were included in the instructions of the drug - joint disease (osteoarthritis) and photophobia. The relevant information is posted in the State Register of Medicines.

The probability of osteoarthritis is assessed as "infrequent." According to the WHO classification, a side effect can occur in every 100th or 1000th who received the vaccine. The frequency data are provided in the product leaflet. It also states that information on adverse reactions was obtained in the framework of clinical trials and pharmacovigilance. As for photophobia, fear of light occurs in those vaccinated with Sputnik V with an approximate frequency.

The updated vaccine instruction also changed the incidence of previously known side effects. Reduced incidence of gastrointestinal disorders - nausea, vomiting, dyspepsia. They can occur "very rarely," the document now says. According to the classification given, one out of 10 thousand vaccinated people manifests themselves.

In addition, new data on its final effectiveness appeared in the document. If in the previous version of the instruction, the efficacy rate was 91% based on the data of the interim analysis of clinical trials (CI), then according to the results of the CI, the vaccine effectiveness was 70.5%.

Also in the instruction, the first component of Sputnik V is equated to Satellite Light"." Those who have been ill COVID-19 and have already been vaccinated with two components are recommended to be vaccinated six months after illness or previous vaccination: antibodies their pronounced growth was noted on the 10th day after vaccination.^[6]

Sputnik V turned out to be twice as effective as Pfizer vaccine against omkiron strain

In January 2022, NICEM named after N.F. Gamalei and the Russian Direct Investment Fund (RDIF) published the results of an independent comparative study conducted at the National Institute of Infectious Diseases named after Lazzaro Spallanzani (Italy). Scientists compared the effectiveness of the Sputnik V vaccine and Pfizer in the fight against the omicron strain of the coronavirus COVID-19.

According to the study, the two-component Sputnik V vaccine forms the geometric mean titer of virus neutralizing antibodies to the coronavirus strain Omicron more than twice as high as two doses of the Pfizer vaccine (2.1 times higher in general and 2.6 times higher three months after vaccination).

The authors explain this superiority of the Russian vaccine by using the original S-glycoprotein (spike protein without proline stabilization and other modifications) and using a heterogeneous vaccination scheme (that is, components based on two different adenoviruses). The Pfizer vaccine, in turn, uses a spiny protein in proline-stabilized form, unlike Sputnik V. Proline stabilization and other modifications, the researchers note, direct the immune response primarily to the actively mutating receptor-binding domain (RBD) of the spike protein. In the "omicron" strain, a significant number of mutations were recorded in this particular domain, so a significant drop in neutralizing activity against this variant can be observed in the serum of those vaccinated with Pfizer, the report said.

The analysis showed that 74.2% of blood sera in Sputnik V vaccinated and 56.9% of blood sera in Pfizer vaccinated contained antibodies to the omicron variant. When reducing the effectiveness of mRNA vaccines (Pfizer also belongs to them) against the omicron strain, experts recommend a booster dose of Sputnik Light^[7]

2021

Endress + Hauser participates in the production of the Sputnik V vaccine

Endress + Hauser devices made it possible to establish a water treatment system for the production of Sputnik V in a short time. This was announced on February 1, 2022 by Endress + Hauser. Read more here.

Europe officially recognized Sputnik V production standards

Europe has officially recognized Sputnik V production standards. This was announced in January 2022 by Denis Logunov, deputy head of the Center named after Gamaleya, who developed this vaccine against the coronavirus COVID-19.

According to him, the European Medicines Agency (EMA) issued a corresponding positive conclusion, which, among other things, concerns the conduct of clinical trials of the Russian drug. Logunov stressed that EMA specialists had no criticisms.

Deputy Head of the Center named after Gamaleya noted that by January 11, 2022, work is underway to harmonize the production standards of Russia with the standards in Europe and China.

Approval of the production of the Sputnik V coronavirus vaccine by the European Medical Agency (EMA) is a positive step, virologist, doctor of medical sciences, professor Anatoly Altstein told 360 TV channel. He suggested that he WHO would recognize the Russian drug in January 2022.

Of course, this is a step in the good direction. There is no doubt that the vaccine will be allowed in some relatively short time. I think there will be a resolution from both the European and World Health Organization this month. There are such chances. There is no reason to believe that our vaccine is worse than those vaccines that have already been approved by this department, "Altstein said.

The conclusion issued by EMA specialists means that they examined the enterprises where the Russian vaccine is produced, and experts recognized them as meeting European requirements. This was told in an interview with "Лентой.ру" virologist, academician of the Russian Academy of Sciences Vitaly Zverev.

According to him, if the issue of recognizing foreign vaccines is raised in Russia, "then we will also have to send someone to foreign enterprises and check the production technology."^[8]

Hungary: Sputnik V better protects against death from COVID-19 than Pfizer, Moderna and AstraZeneca vaccines

At the end of November 2021, the Russian Direct Investment Fund (RDIF) published the results of an independent study of vaccines against the coronavirus COVID-19 in Hungary. According to the results of this work carried out by the National Center for Public Health of Hungary ( NPHC), Sputnik V shows higher protection against deaths (98%) compared to other drugs that are used in the country to vaccinate the population.

The study was conducted on the basis of an analysis of vaccination data by two components of the Sputnik V vaccines, Moderna, Pfizer-BioNTech, Sinopharm and AstraZeneca of Hungarian residents from January 22 to June 10, 2021.

At the beginning of this period, 0.07% of the population of Hungary was fully vaccinated, at the end - 43.16%, during which time 3.74 million inhabitants were vaccinated. Of these, Pfizer chose almost 1.50 million people, Sinopharm - 0.9 million, Sputnik-V - 0.82 million, AstraZeneca - 0.30 million, Moderna - 0.22 million.

Although the authors emphasize that all drugs used in Hungary to prevent coronavirus infection have shown very high effectiveness, one cannot fail to note a large gap in the risk of death for those who were vaccinated with different vaccines. The probability of coronavirus death after Sputnik was 2.56 times lower than for Moderna vaccinated, 3.76 times lower than for Pfizer, 4.68 times lower than for AstraZeneca, and 4.88 times lower than for Sinopharm vaccinated.

According to the RDIF, Sputnik V showed an effectiveness of 85.7% against coronavirus infection and became the leader along with the drug Moderna.

The fund also stressed that among 820 thousand people aged 16 to 44 years vaccinated by Sputnik V, the effectiveness against deaths from coronavirus was 100%.^[9]

About 85 million sets of vaccines against coronavirus "Sputnik V" and "Sputnik Light" were produced

As of November 25, 2021, about 85 million sets of vaccines against the Sputnik V and Sputnik Light coronavirus were produced. This was announced by the director of the National Research Center for Epidemiology and Microbiology named after Gamaleya (developer of these drugs) Alexander Gintsburg.

According to him, 70 million sets of Sputnik V and about 15 million Sputnik Light were released into civilian circulation.

In addition to Sputnik, the country presents the drugs EpiVacCorona and EpiVacCorona-N from the Vector Center of Rospotrebnadzor and KoviVac from the Chumakov Center of the Russian Academy of Sciences. The volumes of their production by the end of November 2021 were not disclosed.

By mid-November 2021, more than 100 million people had been vaccinated with the Sputnik V vaccine outside Russia, Kirill Dmitriyev, general director of the Russian Direct Investment Fund (RDIF), said in an interview with Bloomberg TV.

We expect approval of the vaccine by the end of the year, after a number of bureaucratic procedures, - he said in a conversation with reporters.

The World Health Organization by the end of November 2021 does not announce the date of recognition of the vaccine, the agency writes. The application is in the process of discussion, there is not enough research and data from the Russian side for a final decision.

The head of the RDIF in an interview noted that delays in the supply of Sputnik V outside the Russian Federation, which happened before, have been eliminated. By the end of November 2021, foreign countries receive Sputnik V exactly on schedule.

From January to August 2021, the Gamaleya Research and Production Center placed 11 contracts in Russia for the production of 90.2 million doses of Sputnik V with a total value of 95.2 billion rubles, Kommersant calculated based on data from the public procurement portal. The largest contract for 33.5 billion rubles was placed in early August.^[10]

4 months after vaccination with Sputnik V, actor Valery Garkalin died

On November 23, 2021, it became known that actor Valery Garkalin, who died from the COVID-19 coronavirus, had been vaccinated against this infection a few months earlier - Sputnik V. Read more here.

Gamaleya Center: Sputnik V and revaccination with a nasal drug will protect against coronavirus by 100%

At the end of October 2021, the Gamaleya National Research Center for Epidemiology and Microbiology announced that the use of Sputnik V and subsequent revaccination with a nasal drug would provide 100% protection against not only severe coronavirus (COVID-19) infection, but also from infection with this virus in principle.

We assume, although this will need to be studied during clinical trials, that such immunity will be sterile, that is, the vaccinated person will have not only humoral, but also mucosal immunity at the level of the entrance gate, - said the director of the center Alexander Gintsburg (quoted by RIA Novosti).

According to him, when immunizing with a nasal vaccine, an independent barrier is created for the penetration of the virus at the level of local immunity.

On October 26, 2021, the pharmaceutical company Generium developed and submitted an application for clinical studies of the nasal form of Sputnik V, which is injected into the patient through the nose. According to the general director of the company Daniil Talyansky, such a drug is transferred much milder than a conventional vaccine, and in terms of effectiveness it is in no way inferior to the traditional form of the vaccine.

The Ministry of Health of the Russian Federation issued permission to the Gamaleya Center to conduct the second stage of clinical trials of the nasal vaccine against coronavirus.

The drug "Gam-COVID-Vac," or "Sputnik V," in the form of a spray will be tested on 500 adult volunteers. The research will be carried out on the basis of the Eco-Security Center in St. Petersburg. The test permit was issued until December 31, 2023.

In August 2021, Rinat Maksyutov, General Director of the Vector Center of Rospotrebnadzor, said that vaccines in the form of a nasal spray could be available to Russians in the fall of 2022.^[11]

Argentine Ministry of Health: more serious side effects from Sputnik V than from AstraZeneca vaccine

At the end of October 2021 health care Argentina , the ministry published the results of a large-scale study of the side effects of vaccines against coronavirus, COVID-19 which the population is vaccinated with in the country.

The report covers the period from December 2020 to August 31, 2021. During this time, 43,521,623 doses of vaccines were administered in Argentina, including just over 13 million doses of Sputnik V and 14.6 million doses of AstraZeneca (Covishield). In total, the Argentine Ministry of Health registered 52,649 reports of side effects, or almost 121 cases per 100 thousand doses of vaccinations.

The largest number of reports of side effects was registered in the Sputnik V vaccine - 41.8 thousand. Covishield has 7.3 thousand calls, Sinopharm has 2.8 thousand.

Serious side effects that the researchers associate with vaccines were distributed among the three drugs as follows:

• Sputnik V - 85 cases (0.65 per 100 thousand doses administered);
• AstraZeneca/Covishield - 56 cases (0.38 per 100 thousand doses administered);
• Sinopharm - 17 cases (0.12 per 100 thousand doses administered).

Among the minor side effects when using Sputnik V, the researchers noted headache and muscle pain, joint pain, fever and pain at the injection site.

The study says that the number of undetermined cases of side effects for which there is no direct connection with Sputnik V vaccination has reached 11 from December 2020 to the end of August 2021. Among them - six cases of thrombocytopenia, four cases of Guillain-Barré syndrome and one case of pericarditis. In Covishield/AstraZeneca, the number of cases of thrombocytopenia is a total of 8, Guillain-Barre syndrome - 3, in Sinopharm - one case of thrombocytopenia.^[12]

Britain apologized for fake about Russia's theft of AstraZeneca coronavirus vaccine formula

On October 12, 2021, the British newspaper Daily Express apologized for the publication, which stated that the developers of the Sputnik V coronavirus vaccine allegedly stole the AstraZeneca drug formula.

This article contained false information. As an apology, we are pleased to place a statement from the RDIF, - said in the publication.

The RDIF statement posted in the publication notes that the Sputnik V developers have for many years used the same platform using human adenoviruses as in the case of the COVID-19 vaccine. The fund noted that such a research approach, in particular, was used back in 2017 when creating a Russian drug for Ebola. As indicated in the RDIF, the British-Swedish company, on the contrary, "uses a chimpanzee adenoviral vector for its vaccine, not a human vector."

Material about the "theft of secrets" appeared in the publication The Sun. Its authors Jonathan Reilly and Harry Cole argued that British intelligence agencies have evidence that Russian agents stole critical data for vaccine production in Oxford. At the same time, journalists referred to some reports of the special services, which stated that Russian hackers were attacking British, American and Canadian structures involved in the development of vaccines against COVID-19.

The RDIF called the articles of the British tabloids "fake and blatant lies," and also noted that the data published in the publication are based on anonymous sources. And a spokesman for the Russian president, Dmitry Peskov, said that the British tabloid The Sun is a deeply unscientific publication.

In turn, the former chief sanitary doctor of Russia, Gennady Onishchenko, noted that The Sun journalists who wrote about the theft of the AstraZeneca coronavirus vaccine formula need to undergo a psychological examination. According to him, in such a case, it would be necessary to dismiss employees of the British foreign intelligence agency MI-6 for the loss of professional fitness.^[13]

G20 health ministers call Sputnik V the best COVID-19 vaccine

The health ministers of the G20 countries called Sputnik V the best drug for the prevention of coronavirus (COVID-19) infection. This was announced on September 9, 2021 by the head of the Russian Ministry of Health Mikhail Murashko.

In recent decades, this is probably the first breakthrough in medical science when it is known - a drug - all over the world and trusted. Now at the G20, speaking, health ministers said: "Sputnik" is the best drug for prevention, the minister said.

He also noted that during the COVID-19 pandemic, more than 1.2 thousand new drugs have appeared in the world. Murashko stressed that this has never happened in such a short period of time.

Earlier in September 2021, Mikhail Murashko called on the G20 member countries to jointly recognize certificates of vaccination against coronavirus infection.

Sputnik V has become the world's first officially registered coronavirus vaccine. The authorities of about 70 countries allowed the vaccination of their citizens with this drug (by September 2021). Several countries have launched their own vaccine production. It is allowed to use people over 18 years old, research is underway on adolescents 12-17 years old.

In August 2021, the Russian Direct Investment Fund (RDIF) positively assessed the approval process for the Sputnik V coronavirus vaccine COVID-19 by the European Medicines Agency (EMA) and announced a positive response from experts following the inspection; The RDIF also called the statements of representatives of the European Commission about Sputnik V politicized.

Hungarian Foreign Minister Peter Siyarto on September 9, 2021 noted the popularity of this Russian drug. According to him, all the reserves of Sputnik V in Hungary have been fully used.^[14]

RDIF invested 22 billion rubles in the development and promotion of Sputnik V

The Russian Direct Investment Fund (RDIF) has invested 22 billion rubles in the development and promotion of the Sputnik V vaccine. The head of the fund, Kirill Dmitriyev, announced this on September 2, 2021.

What RDIF has done in order to convince a large number of countries that Sputnik V is one of the safest and most effective vaccines, and RDIF has invested 22 billion rubles in this work, taking on the risk... Investor work in healthcare is certainly very important, "he said.

According to RIA Novosti, citing the press service of the RDIF, the amount of 22 billion rubles includes investments in Sputnik Light in the amount of 17 billion rubles.

According to Kirill Dmitriev, the further strategy of the RDIF is related to the use of the Sputnik Light drug for revaccination, use as an independent vaccine, as well as for using it as a booster.

The head of the RDIF noted that publishing in The Lancet, publishing from other countries where there were Sputnik V studies, conducting clinical studies in India, the UAE, Venezuela and other countries, is what RDIF did to convince a large number of countries that Sputnik V is one of the safest and most effective vaccines in the world.

By the beginning of September 2021, Sputnik V was registered in 70 countries of the world. In early July 2021, the British journal Nature reported that these clinical trials (CI) of the practical use of the Sputnik V vaccine in different countries demonstrate its safety and effectiveness. For example, according to the UAE Ministry of Health, the effectiveness of the drug is 97.8% in preventing symptomatic disease with coronavirus infection and 100% in case of a severe course of the disease. CIs were conducted with the participation of 81 thousand people.^[15]

US pharmaceutical companies want to produce Sputnik V and supply it to other countries

In September 2021, the head of the American Chamber of Commerce in the Russian Federation (AmCham) Alexis Rodzianko said that American pharmaceutical companies are negotiating the possibility of producing the Russian Sputnik V coronavirus vaccine in order to be delivered to other countries.

Combination with AstraZeneci vaccine shows high immunogenicity profile

On August 20, 2021, the R-Pharm group of companies, the Russian Direct Investment Fund and AstraZeneca announced preliminary data on the immunogenicity of the combined use of AstraZeneca vaccine (developed jointly with Oxford University) and the first component of the Sputnik V coronavirus vaccine (Sputnik Light drug based on human adenovirus 26 serotype), obtained as part of a clinical study in the Republic of Azerbaijan. Read more here.

Creation of a modified version of Sputnik V to combat the delta strain

On August 19, 2021, it became known about the creation of a modified version of the Sputnik V vaccine to combat the delta strain of coronavirus. COVID-19 Although the vaccine was created specifically for the sequence of the "Indian" version of the coronavirus, it cannot be understood in advance whether it will work better against it than existing vaccines, said "" To Interfax leader, Gamaleya Center Ministry of Health of Russia academician RAS Alexander Gintsburg.

The refrigerator already has a made vaccine design... Everyone began to make a vaccine based on the sequence of the delta strain, and whether it will be better [existing drugs] against the delta strain, no one can say a priori, "he explained.

On August 18, 2021, the World Health Organization (WHO) announced that the spread of the COVID-19 delta strain is ahead of the measures taken to combat the coronavirus. At the same time, the organization is confident that vaccination "exactly" prevents an increase in the number of severe patients and deaths from the delta strain. According to the Ministry of Health of the Russian Federation, the effectiveness of the Russian Sputnik V vaccine against the COVID-19 delta strain is 83%.

Alexander Gintsburg August 19, 2021, why the "delta" delta strain of coronavirus is especially dangerous:

Now [the most dangerous strain] is 100% "delta." Those who have not been vaccinated, their infectious process proceeds not in two to three weeks, as with other options, but in four to five days. And our immune system with you produces antibodies in 10-12-14 days. With other variants of the coronavirus, she managed to do this, and also brilliant resuscitators helped to hold out for the sick while the immune system worked. And in the case of the "delta" they do not have time.

According to the academician, it is possible that new strains may appear, which may be even more dangerous.^[16]

The effectiveness of the vaccine against the "delta" -stamm of coronavirus is 83%

The effectiveness of Sputnik V against the "delta" state of the coronavirus COVID-19 is 83%. Such an indicator in August 2021 was named by the head of the Ministry of Health RFMikhail Murashko. He clarified that this data was collected in Russia.

According to the minister, Sputnik V protects against severe cases of coronavirus, including those requiring hospitalization, by more than 95%. The vaccine remains effective and continues to work, he said.

Director of the Center. N.F. Gamalei Alexander Gintsburg told reporters that Sputnik V effectively protects against the delta strain and from other numerous strains. Professor of the Department of Virology, Faculty of Biology, Moscow State University, Alexei Agranovsky agreed with this opinion and added that the most effective drug is against the so-called "zero" strain, also known as "Wuhan."

The Sputnik V vaccine was once made against the Wuhan strain, and it defended against it by 95%. Against Delta, it protects by 80%, and this is a lot, this is a high figure. The Zyfras may vary, but so far this vaccine is very effective against the strains that are available, "Agranovsky said.

Earlier, specialists from the Institute for Social Security of San Marino said that Sputnik V shows effectiveness in almost 100% of cases. According to the representative of the institute, Franco Cavalli, antibodies to the coronavirus COVID-19 after the second dose of the Russian vaccine appeared in 99% of the participants in the joint study.

According to data as of August 11, 2021, the Russian Sputnik V vaccine has been registered in 69 countries. However, the drug is still not approved by the European Medicines Agency (EMA). The head RDIF Kirill Dmitriyev said he expects approval from the EMA in the fall of 2021.^[17]

Preliminary results of AstraZeneca and Sputnik Light vaccine combination study received in Azerbaijan

On July 30, 2021, preliminary results of a clinical study of the combined use of the AstraZenek vaccine (developed jointly with Oxford University) and the first component of the Sputnik V vaccine, conducted in the Republic of Azerbaijan, were obtained .

A clinical study to assess the safety and immunogenicity of the combination of vaccines started in February 2021, at the end of July 2021, 50 volunteers were vaccinated in the territory of the Republic of Azerbaijan, recruitment to the clinical trial continues. No serious side effects were detected in volunteers, and not a single case of COVID-19 (COrona VIrus Disease 2019 - coronavirus disease of 2019) was recorded after vaccination.

Gamaleya Center,, the group of Russian Direct Investment Fund companies "" and the R-Pharm company "" AstraZeneca signed a memorandum of cooperation in the development of a vaccine against coronavirus in December 2020.

A joint clinical trial of vaccines takes place within the framework of a global program in several countries at once. As of July 2021, the first results were obtained in Azerbaijan, volunteers are vaccinated in the United Arab Emirates, in Russia and Belarus, national regulators have recently received approval for research.

In August 2021, the first data on the immunogenicity of the combined use of the AstraZenek vaccine and the first component of the Sputnik V vaccine developed by the Gamaleya Center in the Republic of Azerbaijan will be published.

Heterologous prime booster, in which components of different vaccines are administered to a patient, is one of the most promising vaccination schemes for study. It becomes especially relevant when the issue of preventing the spread of emerging strains of coronavirus infection is acute, and the need for revaccination of the population is brewing. That is why the results of the study can be of great importance for those countries where the vaccine developed by AstraZeneca together with the University of Oxford and the Sputnik V vaccine are registered, said Irina Panarina, CEO of AstraZeneca , Russia and Eurasia.

{{quote 'author = noted Vasily Ignatiev, CEO of R-Pharm.|The first results obtained during the spread of the delta strain of coronavirus are very important for assessing the safety and early effectiveness of the combination of vaccines. We will continue to conduct research and analyze the data with the prospect of their publication in an international journal, }}

In the context of the emergence of various strains of coronavirus, the partnership of vaccine manufacturers and the combination of different drugs plays a key role in the successful fight against the pandemic. Based on the high efficiency of the heterogeneous booster approach ("vaccine cocktail"), RDIF launched a partnership initiative with other manufacturers of vaccines against coronavirus. The first such partnership was joint clinical research with AstraZeneca. We look forward to their success in Azerbaijan and other countries, which will make it possible to more effectively implement vaccination programs and protect the health of people around the world. We consider it important to conduct joint research on combining the first component of Sputnik V with drugs from other manufacturers to more effectively combat emerging strains of coronavirus, added Kirill Dmitriyev, CEO of the Russian Direct Investment Fund (RDIF).

Reuters: Reasons for delay in approval of Sputnik V in Europe

In mid-July 2021, it became known about the reasons for the delay in the approval of Sputnik V in. The To Europe agency learned about them Reuters from its own informants.

According to them, the developers of the Russian vaccine against the coronavirus COVID-19 did not transmit data that European regulators consider standard when approving drugs. The refusal to provide the necessary data to several people interacting with the Sputnik V developer was explained by the lack of experience of vaccine developers with foreign regulators.

They are not used to working with a regulator like the European Medical Agency (EMA), "said one of the interlocutors of the publication.

Another claim against the Sputnik developer concerns reporting forms about the negative consequences that people experienced after administering the drug during trials. One of the Reuters interlocutors said that it is standard practice for drug developers to submit such forms. It's also unclear how scientists working on the vaccine tracked results in people who received placebo, the agency's interlocutors said.

The Sputnik V study, conducted separately by French scientists, showed that the vaccine developers could not document that the so-called main cell bank - the original building block of the vaccine - complies with EU standards for preventing disease infection, four informed sources told the agency.

A source close to the EMA clarified that the regulator assesses violations on a scale from "minor" to "critical." According to him, the failures committed by the Russian side are not critical and the main violations can be corrected, although this will require a lot of work.

In June 2021, Reuters reported that the EMA had delayed a review of the safety and efficacy of the drug due to the June 10 deadline for reporting data on clinical trials of the vaccine.^[18]

Serbian Ministry of Health: Sputnik V caused the fewest side effects

In July 2021, the Ministry of Health Serbia reported that Sputnik V caused the fewest side effects compared to other coronavirus vaccines COVID-19 used in the country.

In addition to Sputnik V, Serbian residents can be vaccinated with Sinopharm, Pfizer and AstraZeneca.

We did not have any serious adverse reactions with any of the four drugs used. As for Sputnik V specifically, it, together with another tool, caused the fewest side effects and we are talking about a very high-quality vaccine, so we are proud that we will produce it, "Secretary of State (in the rank of Deputy Minister) of Health of Serbia Mirsad Jerlek told RIA Novosti.

According to him, all doses of the vaccine that Serbia received "from friends and brothers from Russia" have already been used. The deputy minister said that the first Sputnik V vaccines, packaged at the Torlak Institute of Virology, Vaccines and Serums in Belgrade, are expected soon. In the coming weeks, the Gamaleya Institute (developer of Sputnik V) must confirm their quality.

On May 19, Serbian Minister of Industry and Trade Nenad Popovic announced that the Gamaleya Center had approved the production of the Russian vaccine by the Torlak Institute. At the same time, it was noted that Serbia became the first state in Southern Europe to produce Sputnik V.

Already on June 4, 2021,  president RossiiVladimir Putin and Serbian leader Aleksandar Vucic launched the production of Sputnik V in Serbia.

By July 12, 2021, almost half (48.6%) of the adult (over 18 years old) population was vaccinated in Serbia. At the same time, in recent weeks, immunization has been "hard and slow," complained Serbian Prime Minister Ana Brnabic.

According to Serbian Ambassador to Russia Miroslav Lazanski, about 85% of Serbian residents who signed up for vaccination indicated that they would like to be vaccinated with Sputnik V^[19]

The Gamaleya Center recognized a 2.6-fold decrease in the effectiveness of Sputnik V against the Indian strain of COVID-19

At the end of June 2021, the Gamaleya Center recognized a 2.6-fold decrease in the effectiveness of its Sputnik V vaccine against the Indian strain (delta) of the coronavirus COVID-19. This was stated by the developer of the drug and deputy director of the Center. N.F. Gamaleya Denis Logunov. At the same time, he clarified that we are talking about a drop in serum activity.

We are optimistic about the efficiency that we have... There is a fall, but the fall is insignificant, he said, adding that the efficiency of Sputnik V to the Indian strain is estimated at about 90%.

According to Logunov, foreign vaccines have a decrease in the effectiveness against the Indian strain even more - from three to five times.

Deputy Director of the Center named after Gamaleya believes that in the Russian Federation, due to a small layer of vaccinated people, ideal conditions are created for the evolution of infection.

You and I create a small immune layer and a huge percentage of people who are not vaccinated. We have a huge buffer zone for the evolution of viruses, where options can be selected that are thrown over those few vaccinated and create ideal conditions for the evolution of viruses, he said.

By the end of June 2021, the delta version of the coronavirus is actively spreading in Russia. It is assumed that it is twice as infectious as the original (Wuhan) version of SARS-CoV-2. In Russia, the first case of infection with the delta plus virus strain was also detected. According to the Moscow authorities, the Indian strain accounts for about 90% of new cases of COVID-19 coronavirus infection.

Due to the mutation of the coronavirus, it is now necessary to be vaccinated every six months, including those who have been ill, said at the end of June 2021, director of the Center named after Gamaleya Alexander Gintsburg. Coronavirus infection, even in a mild form, is dangerous for the body, he added. According to him, mortality from COVID-19 has already increased from 1-2% to about 5-10%.^[20]

Ministry of Health: Russia pays 900 rubles for the Sputnik V vaccine

On June 7, 2021, the Ministry of Health of the Russian Federation named the cost of the Sputnik V vaccine for the state. Russians receive the drug for free.

Of course, covid caused additional costs. This is primarily the cost of vaccination - Sputnik V costs about 900 rubles, taking into account delivery, all this is paid by the state today, - Russian Health Minister Mikhail Murashko told RIA Novosti in an interview.

According to him, more than 30 million doses of Sputnik V were purchased for vaccination of the population of the Russian Federation by the beginning of June 2021.

Initially, the Ministry of Health of the Russian Federation registered the maximum selling price of the Sputnik V manufacturer at 1942 rubles for two components. Subsequently, the Ministry of Industry and Trade reported that the maximum purchase prices of vaccines produced in Russia range from 844 to 866.81 rubles per dose.

The Russian Direct Investment Fund (RDIF), together with the Gamaleya Center, which participated in the development of Sputnik V, previously reported that one dose of vaccine for other countries will cost less than $10 (the Central Bank rate by June 7, 2021 - 72.9 rubles per dollar). At the same time, vaccination will require two doses, that is, in general, the vaccination price will be no more than $20.

According to the Ministry of Industry and Trade, among Russian vaccines against the coronavirus COVID-19, EpiVacCorona is the cheapest of all drugs that produce immunity against COVID-19 registered in Russia. Its cost is 842 rubles per dose. In second place in price - "KoviVac" - 866 rubles per dose. Thus, Sputnik V turned out to be the most expensive vaccine.

The final purchase price of the one-component Sputnik Light vaccine of the Gamaleya Center is still being discussed by early June 2021. The Federal Antimonopoly Service (FAS) agreed on the cost of the drug at 342.36 rubles.^[21]

The onset of Guillain-Barré syndrome after vaccination in a patient in Moscow

JSC "Medicine" (clinic of academician Reutberg) together with FSAEI HE "RNIIMU N.I. Pirogov " MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION presented a clinical observation of a 47-year-old patient with Moscow the development of clinically confirmed, Guillain-Barré syndrome which occurred 18 days after the introduction of vaccines Sputnik V. This was announced by JSC" Medicine "on Zdrav.Expert May 4, 2021. More. here

Brazil is not allowed to purchase the Sputnik V vaccine

The National Sanitary Supervision Agency of Brazil (Anvisa) did not allow the import of the Russian Sputnik V coronavirus vaccine into the country, claiming "inherent risks" due to lack of information.

Anvisa's five-member board of directors voted unanimously against in April 2021.

At the same time, the Brazilian Ministry of Health signed a contract with the Russian Direct Investment Fund for the production of 10 million doses of the vaccine in March, and on April 26, the country's Ministry of Science recognized the drug as safe and approved its commercial release in the country.

After the introduction of the vaccine, AstraZeneca die 6 times more often than from Sputnik V

In April 2021 Russian Direct Investment Fund (RDIF) , he published the results of a study of mortality after the introduction of coronavirus vaccines COVID-19 different manufacturers. To compile the report, publicly available data from 13 medical regulators USA France Germany Great Britain(,,,,,,,,,,,,, and) were studied. Norway Austria Italy India Argentina Brazil Chile It turned out Denmark Russia that after the introduction of the vaccine, they die 6 times AstraZeneca more often than from Sputnik V. More. here

Vaccine effectiveness 97.6% according to the results of analysis of 3.8 million Russians

According to data provided by the RDIF in April 2021, the effectiveness of the Sputnik V vaccine was 97.6% according to the analysis of data from 3.8 million vaccinated Russians.

India approves emergency use of Russian Sputnik V vaccine

Since April 2021, the drug has become the third coronavirus vaccine allowed in the country after Covishield from AstraZeneca and Covaxin of the local company Bharat Biotech.

The cost of two doses of Sputnik V vaccine in Pakistan is $80

In early April 2021, vaccination against the coronavirus COVID-19 with the Russian drug Sputnik V began in Pakistan. Free vaccinations are provided only for medical workers and citizens over 50 years old. At the same time, residents of the state can receive a vaccine for money - the cost of two doses is 12 thousand rupees ($80). Read more here.

Argentine President confirms COVID-19 infection after Sputnik V vaccination

In early April 2021, it became known about the detection of the coronavirus COVID-19 in the President of Argentina Alberto Fernandez, who had previously been vaccinated against this infection by using the Russian Sputnik V vaccine. Read more here.

Creation of Sputnik V vaccine update technology for COVID-19 mutation

The National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamalei in early April 2021 announced the creation of technology to adapt vaccines against the coronavirus COVID-19 to combat its mutations. The development is based on adenoviral vectors.

According to the sequence of spike protein with a changed primary structure, a new sequence is synthesized literally during the day, and the next day it is inserted into the used vector, and almost you have a genetically engineered structure that allows it to be used as a vaccine drug, ready, - the director of the center Alexander Gintsburg told RIA Novosti.

According to him, by the beginning of April 2021, the question of whether in the case of such development it is necessary to carry out all phases of trials of a new vaccine is being discussed. Gunzburg noted that in world practice there are examples when the drug was tested on a limited sample of up to 100 people.

If it gives the same adequate protective effect, but against the new strain, you can immediately launch it into mass production. I hope that in the near future similar acts will be adopted with us, "said the head of the Gamaleya Center.

The technology for adapting the vaccine when mutating the coronavirus is quite simple, the process can take very little time, said RBC virologist, professor at Moscow State University, Doctor of Biological Sciences Alexei Agranovsky. According to him, not only Sputnik V can be adapted, but also other vaccines against COVID-19.

Earlier, Alexander Gintsburg said that Sputnik V will provide protection against the new strain of coronavirus discovered in Britain. The mutation that distinguishes the "British strain" affects only a "small point" on the surface of the virus, while Sputnik V creates immunity to the entire spike protein of the coronavirus, he explained.^[22]

More than 1000 Muscovites became infected with COVID-19 after two vaccinations with Sputnik V

More than 1000 Muscovites have contracted the coronavirus after two Sputnik V vaccinations. This was announced on March 31, 2021 by the press service of the capital's social development complex.

It is noted that after vaccination with the second component against COVID-19 in Moscow, only 0.1% of those vaccinated fell ill. More than 76% of those infected carry the disease in a mild or asymptomatic form.

As the press service of the Moscow complex of social development reminded Interfax, immunity begins to form after the introduction of the first component of the vaccine. The second spurs the body's immune response and has a longer-lasting effect. However, the formation of immunity to coronavirus after vaccination occurs individually, therefore, after vaccination, it is still necessary to observe precautions.

At the same time, about 1 million people have already been vaccinated against coronavirus in Moscow. About 40% of this number of people are people of the older generation, said the mayor of the city Sergei Sobyanin at the end of March 2021.

We see that this is an absolutely safe and very good vaccine effectiveness. No problem, "he said.

At the end of March 2021, Sergei Sobyanin said that the situation with the coronavirus in Moscow is stable, but there are more patients among the elderly, including those who need hospitalization. According to the mayor's office, 42-43% of Muscovites have antibodies on average. Every day, about 10,000 - 15,000 people are vaccinated in the capital.

On March 22, the president Russia Vladimir Putin said that since the beginning of mass vaccination in January, about 6.3 million Russians have been vaccinated with the first component of the vaccine, of which 4.3 million have received the first and second components of the vaccines.

As of March 31, 2021, 1,026,740 cases of coronavirus infection were recorded in Moscow, of which 944,738 people recovered, 16,656 died.^[23]

Resignation of the Slovak government due to the scandal surrounding the Sputnik V vaccine

At the end of March 2021, the Slovak government resigned due to the scandal surrounding the Russian Sputnik V vaccine. Read more here.

Agreement on the production of 60 million doses of vaccine in China

In March 2021, the Russian Direct Investment Fund (RDIF) and Shenzhen Yuanxing Gene-tech agreed to produce over 60 million doses of Sputnik V vaccine in China.

Natsimbio is a single supplier of the Sputnik V vaccine in Russia

In March 2021, the National Immunobiological Company (Natsimbio, part of Rostec) became the single supplier of the Sputnik V coronavirus vaccine COVID-19 in Russia. Earlier, the logistics for the supply of the drug was carried out by the Immunotechnologies company (part of the Sber group). Read more here.

RDIF agreed to produce 200 million doses of Sputnik V in India

The Russian Direct Investment Fund (RDIF) has agreed to produce 200 million doses of Sputnik V in India. A contract was awarded to Stelis Biopharma (the biopharmaceutical arm of Strides Holding, one of the world's leading pharmaceutical companies headquartered in India). This was announced on March 19, 2021. Read more here.

Dismissal of the head of the Ministry of Health of Slovakia for supporting the Sputnik V vaccine

On March 12, 2021, it became known that the head of the Slovak Ministry of Health, Mareka Krajci, was forced to quit for supporting the Russian Sputnik V coronavirus vaccine COVID-19. Read more here.

Honduras buys 4.2 million doses of Sputnik V vaccine

On March 10, 2021, Honduran President Juan Orlando Hernández announced the conclusion of a contract with the Russian Direct Investment Fund (RDIF) for the purchase of the Sputnik V coronavirus vaccine COVID-19. Read more here.

A contract was signed for the production of Sputnik V in Italy

On March 9, 2021, it became known about the agreement signed by the Russian Direct Investment Fund (RDIF) and the Swiss holding Adienne Pharma & Biotech. We are talking about the production of a vaccine against the coronavirus COVID-19 " Sputnik V" in Italy. Read more here.

Sputnik V is the second most popular vaccine against COVID-19 in the world

In early March 2021, it became known that Sputnik V became the second most popular coronavirus vaccine COVID-19 in the world. The Russian drug was ahead of the number of countries that approved it product Pfizer and is second only to the one AstraZeneca vaccine allowed in 49 states.

By March 5, 2021, Sputnik V is allowed to be used in 45 countries, the Pfizer vaccine in 43. This is followed by the Moderna vaccine (19 countries), as well as three Chinese vaccines: Sinopharm (18), Sinovac (16), CanSino (4). The eighth place is taken by the Johnson & Johnson vaccine, it was approved by four countries, the Russian Direct Investment Fund (RDIF) said on the official Sputnik V page on Twitter.

As clarifies "," RIA Novosti the use of "Sputnik V" by March 5, 2021 was approved in, Russia,, Belarus,, To Argentina, Bolivia Serbia Algeria Palestine,,, To Venezuela Paraguay Turkmenistan,,,, Republic Hungary UAE Iran Tunisia Armenia of Guinea,,,,, Republika To Mexico Nicaragua Srpska (entity of Bosnia and Herzegovina),,,,,, Montenegro Lebanon, To Myanmar Pakistan Mongolia Bahrain Saint Vincent and the Grenadines,,,,,,,,,,,,,,,,,,,,, and. Kazakhstan Uzbekistan Gabon The total San Marino To Ghana Syria Kyrgyzstan To Guyana Egypt Honduras To Guatemala Moldova Slovakia To Angola population of Djibouti 45 Republic of Congo To Sri Lanka Laos countries in Iraq which the Sputnik V vaccine is registered exceeded 1.2 billion people.

On March 4, 2021, the European Medicines Agency (EMA) began an examination of the Sputnik V vaccine. The European regulator expects that the assessment of the drug will take place in a shortened time. Hungary and Slovakia approved the use of Sputnik V on an individual basis, without waiting for the registration of the drug in the EU. By March 5, RDIF is negotiating the use of Sputnik V in Austria.^[24][25]

Map of countries that agreed to buy or produce the Sputnik V vaccine

Panama buys 3 million doses of Sputnik V vaccine

Panama has decided to purchase 3 million doses of the Russian COVID-19 coronavirus vaccine to inoculate about half of the country's population. The Ministry of Health of Panama sent a corresponding letter to the Russian Direct Investment Fund (RDIF), which oversees the promotion of the drug abroad. Read more here.

The Ministry of Health of the Russian Federation explained the difference between the Sputnik V and EpiVacCorona vaccines

At the end of January 2021, the Ministry of Health spoke about the difference between vaccines against the coronavirus COVID-19 Sputnik V and EpiVacCorona. As emphasized in the department, both drugs reliably protect against coronavirus infection, but their mechanism of action is different. Their main differences are that Sputnik V was obtained by biotechnology, which does not use the pathogenic COVID-19 virus for humans.

According to the explanation on the website of the Ministry of Health of the Russian Federation, Sputnik V is a neutralized adenovirus particles that do not multiply in the human body. When creating a vaccine, their genetic basis was removed, and instead a gene with a code of a special protein ("spike" of coronavirus) was introduced into the virus particle. This protein does not pose any danger to humans. It helps the immune system to respond correctly to the virus and produce antibodies (immunoglobulins) to it, which will further protect against infection. To fully protect the patient, it is necessary to make two injections with adenoviruses of different types with an interval of 21 days. The first stage triggers the immune response, and the second accelerates and enhances it.

The EpiVacCorona vaccine, in turn, contains artificially synthesized peptides (small proteins) of the coronavirus. The vaccine uses three types of peptides, as well as carrier proteins and excipients that are needed to penetrate the vaccination components into the body. These peptides are recognized by the immune cells of the vaccinated person, and antibodies are produced to them. If after vaccination a person meets with a "real" coronavirus, his immune system "recognizes the enemy by his peptides" and repels the attack, the Ministry said. health care Russia The vaccine is also given twice with an interval of 14-21 days.^[26]

Vaccine deliveries to Malaysia

On January 26, 2021, it became known about the contract for the supply of the Sputnik V coronavirus vaccine COVID-19 to Malaysia. This agreement was concluded by the Russian Direct Investment Fund (RDIF) and the Malaysian pharmaceutical company Duopharma Sdn Bhd. Read more here.

Hungary approves Russian Sputnik V vaccine

On January 21, 2021, it is known that Hungary became the first country in the European Union to approve the use of the Sputnik V coronavirus vaccine COVID-19. The drug was registered by the National Institute of Pharmacology and Nutrition of Hungary (OGYÉI).

According to the Russian Direct Investment Fund (RDIF), Sputnik V is registered in Hungary as part of an accelerated procedure (emergency use authorization) based on data from Sputnik V clinical trials in Russia and a comprehensive assessment of the drug by experts in Hungary. It is noted that according to a similar procedure, the Russian vaccine was previously registered in Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay and Turkmenistan. The drug is also registered in Russia and Belarus.

Hungary is the first EU country to assess the benefits of the Russian Sputnik V vaccine and approve its use on its territory, comments RDIF CEO Kirill Dmitriyev. - This is the most important solution that demonstrates a high assessment of the safety and efficacy of the vaccine at the level of more than 90% by our partners in Hungary.

On January 20, 2021, it became known that Moscow had applied for the registration of Sputnik V in the European Union. Within 7-10 days, experts representing the European Medicines Agency (EMA) will send recommendations to the drug developers. The RDIF expects that the process of gradual examination will begin in February. Only after that will the EU be able to make a final decision on the registration of the drug.

The fund said it was discussing the launch of full-fledged vaccine production in the EU, for example, in Germany. But in Berlin they noticed that this can only be thought about after the registration of the vaccine in the European Union.

By January 21, 2021, there are more than 1.5 million people in the world who have received the Sputnik V coronavirus vaccine (RDIF data). The cost of the vaccine is less than $10 per injection.^[27]

Algeria purchased 500 thousand doses of Sputnik V vaccine

As it became known on January 18, 2021, Algeria purchased 500 thousand doses of the Russian vaccine against the coronavirus COVID-19 Sputnik V. The batch of drugs will arrive in the North African country before the end of the month. Read more here.

2020

Sputnik V gives side effects in only 1% of vaccinated in Argentina

In early January 2021 Ministry of Health of Argentina (Ministerio de Salud) , it published a report on the use of the Russian coronavirus vaccines COVID-19 Sputnik V. According to the ministry, complications were detected in only 1% of people who were vaccinated with this drug. More. here

Bolivia buys 2.6 million doses of Sputnik V vaccine

Bolivia buys 2.6 million doses of the Russian vaccine against the coronavirus COVID-19 Sputnik V. This was announced on December 30, 2020 by the Russian Direct Investment Fund (RDIF, the sovereign fund of the Russian Federation), which signed a corresponding contract with the General Directorate for Procurement and Supply in the Healthcare Sector ( Central de Abastecimiento y Suministros de Salud, CEASS) of the Multinational State of Bolivia. Read more here.

Start of deliveries of the Sputnik V vaccine against COVID-19 in the Russian Federation, produced in South Korea

Russia COVID-19 The first Sputnik V South Korea batch of the drug was delivered by Asiana Airlines Moscow on December 25, 2020, and the second on December 29. In January 2021, the vaccine is expected to be delivered to other countries. More. here

Sputnik V vaccine against COVID-19 is included in the calendar of preventive vaccinations

Since December 27, 2020, the vaccine against the new coronavirus infection has been included in the National Calendar of Preventive Vaccinations for Epidemic Indications. Vaccination against COVID-19 with the first Russian vaccine "Sputnik V (Gama-Kovid-Vak)" is available to every insured free of charge with a compulsory health insurance policy.

Start of deliveries of Sputnik-V vaccine for large-scale vaccination in Russia

The biotechnology company Biocad began to supply COVID-19 vaccine Gamaleya Center in for large-scale vaccination against in coronavirus the country. Biocad announced this on December 16, 2020. More. here

Sputnik V vaccine production begins in Kazakhstan

On December 21, 2020, it was announced the launch of the production of the Russian vaccine against the coronavirus COVID-19 Sputnik V in Kazakhstan. The drug began to be produced on the basis of the Karaganda pharmaceutical complex. Read more here.

Not a single Sputnik V vaccinated had a severe case of infection COIVD-19

The effectiveness of Sputnik V against severe cases of coronavirus infection COVID-19 was 100%. This was announced on December 14, 2020 by the Russian Direct Investment Fund (). RDIF

It is noted that among the confirmed cases of coronavirus infection in the placebo group, 20 severe cases of the disease were recorded, while in the group taking the vaccine, there were no such cases at all - all cases of coronavirus infection in the vaccinated group were mild.

In general, the effectiveness of Sputnik V in the final checkpoint of clinical trials was 91.4%. The calculation of this indicator was carried out on the basis of data on 22,714 volunteers who received the first and second injections of the Sputnik V vaccine or placebo, at the third and final checkpoint - 78 sick volunteers, of which 16 received the vaccine, the rest - placebo.

In total, by December 14, 2020, about 26 thousand volunteers were vaccinated with the drug. Unexpected adverse events after vaccination did not manifest themselves, and only short-term pain at the site of vaccine administration and influenza-like syndrome were observed, including fever, weakness, fatigue and headache. The analysis was carried out after 21 days from the time volunteers received the first component of the vaccine.

NICEM named after N.F. Gamalei The Ministry of Health of the Russian Federation and the Russian Direct Investment Fund announce the effectiveness of over 90% of the Russian Sputnik V vaccine based on the results of data analysis at the final checkpoint as part of the third phase of the largest in the history of Russia double-blind randomized placebo-controlled clinical post-registration study of the Sputnik V vaccine against a new coronavirus infection, the RDIF noted.[28]

Argentina buys 10 million doses of Sputnik V coronavirus vaccine

On December 10, 2020, it became known about the supply coronavirus vaccines COVID-19 of Russian "." Sputnik V The Argentina Russian Direct Investment Fund (RDIF) and the government of the South American country signed a contract involving the transfer of 10 million doses of the drug. More. here

The start of mass vaccination against COVID-19 in Russia

On December 11, 2020, Prime Minister Mikhail Mishustin announced the start of mass vaccination against the coronavirus COVID-19. Russians will be injected with the drug "Sputnik V."

Today I can say that we fit on time. The first batches of the vaccine have already been sent to the regions, and gradually we are entering its planned production, - said the head of the Government of the Russian Federation on the air of the Russia 24 TV channel.

According to him, in December 2020, the regions will receive about 480 thousand doses of vaccine. Ministry of Health countries have formed a schedule for the distribution of the drug by subject. Mishustin stressed that the authorities are meeting the deadline for the start of large-scale vaccination set by the president, Russia Vladimir Putin Mishustin said.

The Prime Minister recalled the need to ensure vaccination on New Year's holidays, urging the governors to personally control the process. The first vaccination points outside the Moscow region opened on December 11, 2020, their number will increase as the supply of the drug increases. Mishustin demanded that the heads of the subjects personally control the vaccination process.

Mikhail Mishustin believes that Russia occupies a leading position in the world in organizing vaccination of the population.

We are proud of our scientists and doctors, without whom these successes would be impossible, "he stressed at a meeting with vaccine manufacturers.

The head of government on December 11, 2020 also announced that post-clinical trials of a new vaccine produced by the Vector Center had begun. Their results will be summed up in January 2021, and then the wider use of this vaccine will begin.

The head of the Gamaleya Center, Alexander Gintsburg, noted that as of December 10, more than 150 thousand residents of the Russian Federation had already been vaccinated against COVID-19 with the Russian drug Sputnik V as part of a civil turnover.^[29]

AstraZeneca has begun testing its vaccine in conjunction with Sputnik V

On December 11, 2020 AstraZeneca , she announced the start of tests of her coronavirus vaccines COVID-19 own in conjunction with the Russian drug Sputnik V, which is also intended to fight this infection. More. here

COVID-19 infection occurred in only 1.4% of participants in clinical trials of the vaccine

Only 1.4% of participants in clinical trials of the Sputnik V vaccine were infected with the COVID-19 coronavirus. This was announced on December 4, 2020 by the Deputy Mayor of Moscow for Social Development Anastasia Rakova.

According to her, more than 20 thousand people received both doses of the vaccine as part of post-marketing clinical trials. Among them were 273 cases of coronavirus infection.

Some people received a placebo. Which of them received a placebo, we do not know. That is, these figures themselves speak for themselves about the effectiveness of this vaccine, - said the vice-mayor.

According to her, for six months of preparation and conduct of clinical studies of Sputnik V, a full logistics chain of the vaccination process was deployed in Moscow, including ensuring the correct storage conditions, including during transportation.

Alexander Gorelov, deputy director for scientific work of the Central Research Institute of Epidemiology of Rospotrebnadzor, says that coronavirus infection after vaccination is possible, but the disease will be easier.

There is no absolute protection, but the infection in vaccinated people is easier and without complications, "he said, adding that infection after vaccination is possible with other infections.

According to the director of the Irkutsk Research Anti-Plague Institute of Siberia and the Far East, Doctor of Medical Sciences, Professor Sergei Balakhonov, there are no vaccines with 100% protection against infection. In the world long-term practice of working and permissible for mass use, a vaccine with an efficiency indicator of more than 50% is considered, he noted.

Balakhonov said that a large dose of the pathogen that has entered the body of the vaccinated person can, in particular, cause the so-called immune breakthrough, so there is a possibility of infection for the vaccinated.^[30]

Electronic record for vaccination against COVID-19 opens in Moscow

On December 3, 2020, Moscow Mayor Sergei Sobyanin announced the opening of an electronic record for the introduction of a vaccine against the coronavirus COVID-19. It will be possible to sign up for the vaccination from December 4, and get it from December 5. Read more here.

Mass vaccination against COVID-19 began in the Russian army

On November 27, 2020, Defense Minister Sergei Shoigu announced the start of mass vaccination against the coronavirus COVID-19 in the Russian army. Servicemen are injected with the drug "Sputnik V."

In accordance with the instructions of the president, vaccination of the personnel of the Armed Forces against the new coronavirus infection began. In total, it is planned to vaccinate more than 400 thousand military personnel, he said (quoted by Interfax).

According to Sergei Shoigu, by September 27, 2020, more than 2.5 thousand servicemen were vaccinated against coronavirus, and by the end of the year it is planned to vaccinate 80 thousand people.

In addition, the Armed Forces of the Russian Federation are conducting research on the use of plasma from vaccinated military personnel with a high titer antibodies for the treatment of COVID-19. This method of treatment has demonstrated its effectiveness in combating a severe form of the disease, Shoigu added. By the end of November 2020, more than 500 vaccinated military personnel are involved in the studies.

In early September 2020, Sergei Shoigu was vaccinated with a domestic drug for coronavirus. Then the minister announced the absence of any side effects from the administration of the drug.

Quite normal. I had no fever or any other side effects, "he said, recommending everyone be vaccinated.

At the same time, Shoigu said that doctors and commanders of all levels would be the first in the army to be vaccinated on a voluntary basis.

Earlier, the press secretary of the President of Russia Dmitry Peskov said that mass vaccination of the country's population should begin before the end of 2020. However, he did not give an exact date. The authorities, including Prime Minister Mikhail Mishustin, have repeatedly stressed that vaccination against coronavirus will be voluntary.^[31]

RDIF signed a contract for the annual production of 100 million doses of Sputnik V vaccines in India

On November 27, 2020, the Russian Direct Investment Fund (RDIF) announced the conclusion of a contract with the pharmaceutical company Hetero for the annual production of 100 million doses of the Sputnik V coronavirus vaccine COVID-19 in India. Read more here.

Start of production of dry form "Sputnik V"

On November 24, 2020, it was announced the start of production coronavirus vaccines COVID-19 of Sputnik V, which is stored at a temperature of + 2 to + 8 ° C. We are talking about a dry (lyophilized) form of the drug, reported in Russian Direct Investment Fund (RDIF).

This regime allows the vaccine to be distributed in international markets, as well as expand its use in hard-to-reach regions, including areas with a tropical climate, the foundation said in a statement.

Earlier, the director of the Oxford Vaccine Group, Andrew Pollard, said that the coronavirus vaccine developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca could be distributed around the world due to the fact that it can be stored in the refrigerator. The American company Moderna also said that its coronavirus vaccine can be stored in a regular refrigerator for a month.

Vaccine from Pfizer created on the basis of RNA. The mechanism of protection and safety of such drugs has not yet been fully studied, experts say. Most likely, low temperatures are critical during transportation, and then they can be stored under normal conditions for a fairly long time, believes Evgeny Timakov, vaccinologist, head physician of the Leader of Medicine medical center.

As for the vaccine against coronavirus, which must be stored at -80 degrees Celsius, this may be due to the fact that the vaccine itself is initially stored at this temperature, but in further conditions of use you need to understand, - he said in a conversation with Kommersant.

The vaccine against COVID-19 "EpiVacCorona" of the "Vector" center of Rospotrebnadzor can also be stored at a temperature of 2 to 8 ° C. The non-dry form of Sputnik V can be stored at minus 18^[32]

Sputnik V coronavirus vaccine will also be produced in Hungary

The Sputnik V coronavirus vaccine will also be produced in Hungary, Kirill Dmitriyev, head of the Russian Direct Investment Fund, said on November 24, 2020. Read more here.

Vaccine effectiveness exceeded 95%

The effectiveness of the Sputnik V coronavirus vaccine COVID-19 on the 42nd day after the first injection exceeded 95%, according to the official website of the drug on November 24, 2020.

At the same time, the effectiveness of using Sputnik V based on the second intermediate analysis of data on the 28th day after the first vaccination for volunteers (corresponds to the seventh day of receiving the second immunization) was 91.4%.

The calculation of effectiveness was carried out on the basis of an analysis of data on 18,794 volunteers who received the first and second injections of the Sputnik V vaccine or placebo, at the second checkpoint - 39 sick volunteers as of November 23, 2020.

In the control group that received a placebo, 31 out of 4,699 people fell ill with COVID-19. In the test, the participants of which were vaccinated against coronavirus, eight out of 14,095 people were infected.

As specified in the material, Gamaleya Center it also tests the vaccine in,, and Belarus UAE To Venezuela several other countries. The second and third phases of the tests take place in. India

In NICEM named after N.F. Gamalei said that unforeseen side effects have not yet been recorded, although some volunteers had pain at the place of administration of the drug, fever, weakness, fatigue and headache.

Data on the high effectiveness of the Sputnik-V vaccine give us hope that soon we will receive the most important tool in the fight against the pandemic of the new coronavirus infection, - the words of the Minister of Health Mikhail Murashko are quoted in the release

The intermediate data obtained during the research will be published by the scientific team of the N.F. Gamalei Scientific Research Institute in one of the leading international peer-reviewed medical journals. At the end of phase III clinical trials, the Sputnik V vaccine of the N.F. Gamalei Research Institute will provide access to a full report on clinical trials.^[33]

Seventh place in the ranking of the most popular vaccines against COVID-19

At the end of November 2020, Bloomberg published a rating of the most popular vaccines against the coronavirus COVID-19 according to the calculations of the London research firm Airfinity. Sputnik V is in 7th place, and the AstraZeneca vaccine tops the list, which most of the world counts on, with the exception of very rich countries like the United States. Read more here.

Kazakhstan will build a plant for the production of the Russian vaccine against COVID-19

On November 16, 2020, President Kazakhstan Kassym-Jomart Tokayev announced that a production enterprise would be launched in the country. Russian coronavirus vaccine COVID-19

I have reached an agreement with the President of Russia on the construction of a plant for the production of Russian vaccine. The government has already begun negotiations on attracting investments in this necessary project, - he said during a meeting with members of the government, heads of a number of state bodies, akims of cities and regions.

On November 11, 2020, Kassym-Jomart Tokayev and Russian President Vladimir Putin held a telephone conversation, during which, in particular, they touched upon a number of pressing topics on the bilateral agenda with an emphasis on intensifying cooperation in the fight against the coronavirus pandemic, including plans to organize joint production of vaccines in Kazakhstan.

Dozens of countries have expressed interest in organizing the supply and joint production of Russian vaccines against coronavirus, Vladimir Putin said earlier during his speech at the East Asian Summit.

Tokayev did not specify either the timing of the construction of the enterprise, or the name of the drug that will be produced there.

In August 2020, the Kazakh state distributor SK-Pharmacy signed an agreement with the Russian Direct Investment Fund (RDIF) on the supply of the Sputnik V vaccine to Kazakhstan.

The government of Kazakhstan plans that immunization of citizens of the country who are at risk will be carried out on a free and voluntary basis.

According to official data, by November 16, 2020, 121,051 cases of coronavirus infection were recorded in Kazakhstan, 109,944 people recovered, 1899 people died. Over the week, mortality from COVID-19 in the country increased by more than 16%, according to data from the local Ministry of Health.^[34]

South Korea to produce 150 million doses of Sputnik V vaccine for export

On November 13, 2020, an agreement was announced between the Russian Direct Investment Fund (RDIF) and GL Rapha. Under the terms of the agreement, the South Korean biopharmaceutical company will annually produce 150 million doses of vaccines against the coronavirus COVID-19. Read more here.

Chinese company Tibet Rhodiola Pharmaceutical Holding receives rights to produce Sputnik V vaccine

Tibet Rhodiola Pharmaceutical Holding received the rights to sell and test the Russian vaccine against the coronavirus COVID-19 Sputnik V. The Chinese company itself announced this on November 11, 2020. Read more here.

The effectiveness of the Pfizer vaccine and Sputnik V turned out to be the same - 92%

The effectiveness of the Sputnik V vaccine is 92%. This was reported on November 11, 2020 on the official website of the drug. The calculation was based on the distribution of 20 confirmed cases identified in the placebo group and in the vaccine-treated group. Read more here.

Launch of mass production of Sputnik V coronavirus vaccine

On November 11, 2020, the head of the Ministry of Health of the RFMikhail Murashko announced the start of mass production of the Sputnik V coronavirus vaccine COVID-19. According to the minister, the drug began to spread throughout the Russian regions.

Industrial scale is increasing. Manufacturers have worked out technological regulations and are launching mass production, - said Murashko at the Meeting of Health Ministers of the BRICS countries (quoted by TASS).

He also noted that by November 11, 2020, studies of several more promising vaccines are continuing in Russia. In particular, "multicenter studies" and clinical studies of an inactivated vaccine developed in the Russian Federation are being carried out.

Digital resources are used to assess vaccine efficacy and safety. For the first time in the world, we have developed a global format for interaction between an information system and a mobile application for quality control and tolerability of a drug, which allows us to have a real world of data on this vaccine, "the head of the Ministry of Health emphasized.

On November 11, 2020, the director of the Gamaleya Center, Alexander Gintsburg, said that mass vaccination against coronavirus in Russia could begin in the coming weeks. According to him, vaccination will achieve a significant reduction in the incidence of COVID-19 and turn the tide.

The academician notes that thanks to the scaling of production and the connection of new production sites, the Sputnik V vaccine will become available to the general population. By November 11, 2020, risk groups - doctors, doctors and teachers - are actively vaccinated in Russia.

This will reverse the current trend and achieve a decrease in the incidence of coronavirus infection, first in Russia, and then around the world, the scientist said.[35]

Doctors in Altai infected with coronavirus after vaccination with Sputnik V

On November 10, 2020, the Ministry of Health of the Altai Territory announced the detection of the coronavirus COVID-19 in three of 42 doctors who were given a vaccine against this infection. The department explained the infection of medical workers vaccinated with Sputnik V by the fact that they did not have time to develop antibodies.

The vaccine is two-component: three weeks after the first injection, the person receives the second. A person is considered vaccinated and, accordingly, protected from coronavirus infection only three weeks after the second vaccination, since all this time the process of forming immunity is underway. Immunity in sick doctors who have been vaccinated, probably, did not have time to form by the time of meeting with the causative agent COVID-19. Only this could cause infection of doctors, - said in the message of the Altai Ministry of Health.

The assistant Minister of Health of the Russian federation Aleksei Kuznetsov , in a conversation TASS with, confirmed that cases of positive PCR testing results in persons who received the vaccine are usually due to the fact that by the time they met with the causative agent COVID-19, they did not have time to form immunity, since an insufficient amount of time has passed since vaccination.

According to Alexei Agranovsky, professor of the Department of Virology at the Belozersky Institute of Moscow State University, Doctor of Biological Sciences, the coronavirus vaccine does not guarantee the rapid appearance of antibodies, and the risk of COVID-19 infection remains between injections. The virus could appear in the body earlier than antibodies, because of which the infection could develop, he said.

If they had an infection a month after vaccination, then it compromises the vaccine, and this is a consequence of such circumstances, - said the virologist, adding that what happened could be associated with an individual reaction to the vaccine and various innate immunity.[36][37]

Suspension of vaccination of volunteers due to drug deficiency

At the end of October 2020, it became known about the suspension of trials of the Sputnik coronavirus vaccine COVID-19. The reason is the shortage of the drug due to high demand.

According to Reuters, a representative of Crocus Medical, which helps to conduct vaccine trials, told the agency that the demand for Sputnik V is "colossal" and there is not enough vaccine production to cover it. According to the news agency, it is planned to resume vaccination of new test participants on November 10, 2020.

Employees of eight of the 25 Moscow clinics that are testing the vaccine also told the agency about the suspension of vaccination of new volunteers. Several clinics told the agency that they had run out of vaccine doses and noted a large flow of volunteers.

Try it next week! - employees of the vaccine research center in Chertanov told potential volunteers.

However, the head of the Gamaleya Center, Alexander Gintsburg, assured that trials of the drug are ongoing, there is enough vaccine for research. According to him, the gap between the first and second doses is quite significant - the first component has already received 20 thousand volunteers, and the first and second - about 9 thousand. They decided to narrow the gap and vaccinate more with the second component than the first one per day.

The assistant minister health of the Russian Federation Aleksei Kuznetsov said that all 40 thousand volunteers will be vaccinated with the Sputnik V vaccine.

It was previously planned to produce 30 million doses of the Sputnik V vaccine by the end of 2020, but subsequently the plans were reduced to 2 million doses. At the end of October 2020, Russian President Vladimir Putin announced difficulties in production.

There are certain problems associated with the presence or absence of a certain amount of equipment - "iron," as they say - for the deployment of mass production, - said the head of state.[38]

Several participants in Sputnik V vaccine trials infected with COVID-19

At the end of October 2020, it became known about the infection of COVID-19 by several participants in clinical trials of the Sputnik V vaccine, which is designed to protect against this coronavirus.

As the director of the Gamaleya Center, which developed the drug, Alexander Gintsburg, told RIA Novosti, volunteers who took part in the studies who tested positive for coronavirus could not receive a vaccine, but a placebo. He noted that it will be possible to previously establish who received the drug and who received the substance without therapeutic properties in mid-November 2020.

The contingent of infected among the participants in post-registration tests will be determined after decoding the results of the studies. With a high probability, there will be those who received a placebo, or at the time of contact with the virus did not pass the full course of vaccination, - explained the director of the Gamaleya Scientific Center.

According to Gunzburg, half of the volunteers have already received the first component of the vaccine, about 9 thousand have been vaccinated for the second time. The vaccine involves the introduction of two components of the drug with a difference of three weeks. During the tests to test the effectiveness of Sputnik V, 10 thousand out of 40 thousand participants will receive placebo. Test participants will be able to find out what was injected into them only after the end of the research.

Alexander Gintsburg says that a decrease in the level of antibodies 2-3 months after vaccination against COVID-19 is normal. According to him, cellular immunity formed by the vaccine will give repeated synthesis of antibodies to coronavirus.

Gunzburg explained that the practice of using the Ebola virus vaccine, on the principle of which the Sputnik V vaccine was created, shows that cellular immunity remains for two years. He also added that the production of doses of the Sputnik V vaccine intended for civilian circulation should increase from the beginning of November 2020 due to an increase in the number of sites.^[39]

Czech entrepreneur launches tours to Russia (Sputniktrip) for vaccination against COVID-19

At the end of October 2020, a businessman of Russian origin living in Prague, Andrei Konstantinov, announced the organization of tours in Russia, implying vaccination against the COVID-19 coronavirus. A product called Sputniktrip is offered at a price of 30 thousand Czech crowns (about 100 thousand rubles). Read more here.

Generium received the rights to produce a vaccine against coronavirus COIVD-19 Sputnik V

On October 26, 2020, it became known that the Ministry of Health of the Russian Federation issued a registration certificate to the research and production company Generium, giving it the right to produce a vaccine against the coronavirus COVID-19 Sputnik V. Read more here.

The start of the second stage of vaccination against COVID-19 in Moscow

At the end of September 2020, the second stage of vaccination against the coronavirus COVID-19 began in Moscow. Participants in the post-registration clinical study began to receive the second component of the Sputnik V drug, Anastasia Rakova, Deputy Mayor of Moscow for Social Development, told reporters.

The second component of the coronavirus vaccination has already received six study participants. Today [September 30, 2020 - approx. Zdrav.expert] it is planned to vaccinate about 20 people. "Sputnik V" is a two-component vaccine, and a second inoculation is necessary to enhance the immune response resulting from the first administration. According to the results of the first vaccination, and more than 5.7 thousand people have already made it, we see that the absolute majority feels good, "she said.

The gap between the introduction of the first and second components of the Russian vaccine against COVID-19 is 21 days, the vice mayor recalled. The components differ in the active substances included in their composition.

The second stage of vaccination has already begun in those medical organizations where the first participants in the study were vaccinated. There are four such institutions: polyclinics No. 2, 62 and 220, as well as on the basis of the polyclinic department of the Konchalovsky City Clinical Hospital. In the coming days, the second stage starts in all institutions involved in the study.

By September 30, 2020, 19 Moscow medical organizations can take part in the study. As Rakova noted, "conducting the study will help to obtain a permanent registration certificate and expand the range of possible recipients of the vaccine, including covering the 60 + age group." She added that the study lasts 180 days.

You can apply for participation in a clinical trial of a vaccine against COVID-19 on the portal mos.ru.^[40]

Agreement to supply 25 million doses of vaccine to Nepal

On September 29, 2020, it became known that the Russian Direct Investment Fund (RDIF) and one of Nepal's largest pharmaceutical distributors Trinity Pharmaceuticals agreed to supply 25 million doses of Sputnik V coronavirus vaccine to Nepal.

Medical institutions in Nepal will receive a vaccine against coronavirus in an amount sufficient for 90% of the country's population.

Sending a batch of vaccines to all regions of Russia

On September 24, 2020, the Ministry of Health of the Russian Federation announced the supply of the Sputnik V coronavirus vaccine against COVID-19 to all regions. The transferred drugs are digitally labeled. Small batches of the vaccine were shipped to the constituent entities of the Russian Federation primarily for healthcare workers.

In addition to medical workers, priority groups for vaccination are employees of educational organizations, police, public transport, trade, social protection bodies, catering establishments, as well as employees whose work is related to contact with a large number of people. Priority will also be given to students in organizations of secondary and higher vocational education and conscripts.

As noted in the press service of the department, according to the Federal State Information System for Monitoring the Movement of Drugs, more than 27 thousand packages of marked Sputnik V vaccines are in circulation. Their volume is increasing.

The Gamaleya Russian Institute has begun clinical trials of the Sputnik V vaccine on a number of risk groups. As the head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriyev told RIA Novosti on September 24, 2020, elderly people are participating in the tests among risk groups.

By September 24, 2020, post-registration trials of the Sputnik V vaccine continue in Moscow. The vaccination of volunteers as part of clinical trials of the coronavirus vaccine of the Vector Center has also been completed. The drug has passed two phases of clinical trials. During the research, 100 volunteers were vaccinated.

The sending of the first batch of vaccine to the regions became known on September 12, 2020. Then the Ministry of Health noted that within the framework of the pilot program, logistics chains, distribution and organization of vaccinations against coronavirus for citizens at risk will be worked out.^[41]

Biocad will release a vaccine

On September 24, 2020, the biotechnological company Biocad announced the signing of an agreement with the Research Center for Epidemiology and Microbiology named after GamaleyaMinistry of Health of Russia on the industrial production of the vaccine. Biocad becomes an industrial partner of the scientific center and will provide mass production of the Sputnik V vaccine.

For September 2020, post-registration clinical trials of the vaccine are being carried out. It is known that the vaccine is two-component, revaccination is carried out from intervals of 3-4 weeks. Moreover, when a particle of coronavirus RNA is reintroduced, it is covered with a new adenovirus. This is done in order to exclude the presence of antibodies to the vaccine in humans and thus increase the reliability of its effect.

{{quote 'Since the beginning of the pandemic, Biocad has repeatedly stated that it is ready to become an industrial partner for any project, aimed at developing a vaccine against coronavirus, - Dmitry Morozov, General Director of the biotechnological company BIOCAD, commented on the signing of the agreement on the part of the manufacturer. - We carefully read the results of our colleagues and made sure, that vaccine studies conducted by a team of a scientific institute led by Alexander Ginzburg, showed that this is a working version, effective and safe enough to ensure the vaccination of Russian citizens. The mass release of the vaccine will allow scientists to complete the third stage of clinical trials, to which many volunteers were attracted, and begin supplying the drug to the regions of Russia, as well as abroad. }}

In addition to the production of a liquid vaccine, the partners plan to establish the production of a lyophilized (powder) vaccine. Dry vaccine does not require special storage conditions during transportation, and this is its main advantage.

The production of the dry vaccine was temporarily frozen, since the Center does not have such capacities for freeze drying in order to provide the country with serious quantities, - said Alexander Gintsburg, director of the Center named after Gamaleya. - Now that Biocad, which has lyophilization capacity, has joined us, we hope that the dry vaccine will be produced in the right quantities.

Biocad recalled that in early September 2020 he launched a high-tech production complex in Zelenograd with a total area of ​ ​ 43 thousand square meters. m. Thus, the company has 6 PCs in Russia, four of which are located in Moscow and the Moscow region. In total, as of September 2020, the company employs over 2.5 thousand people, 1000 of whom are involved in its research activities. This is the fourth vaccine development project in which Biocad is involved, two developments are in-house.

Side effects

September 18, 2020 Director of the Center named after Gamaleya Alexander Gintsburg said that the Russian vaccine against the coronavirus COVID-19 "Sputnik V" does not cause serious side effects. At the same time, some ailments can still occur.

According to Gunzburg, about 14-15% of those who received the vaccine increased their temperature to 37.5-38 degrees, there were aches in the back, headache, discomfort, redness at the injection site. However, these are standard manifestations for all vaccines, he stressed.

Now about 800 people have been vaccinated, some of them have a placebo - it turns out that about 600 people have already been vaccinated as part of the study, everyone in a row, there are no serious "side effects," - said the head of the Center named after Gamaleya, adding that by September 18, 2020 there are no new contraindications for the use of the vaccine.

Earlier, Gunzburg, in a conversation with Interfax, noted that contraindications for vaccination against coronavirus, as well as against other infections, are "serious chronic autoimmune diseases, so as not to exacerbate them, arthritis, arthrosis, acute stages, pollinosis, allergies to food."

Gunzburg believes that for pregnant women there is also "no special need to use a vaccine," but, in his opinion, it is better to get vaccinated against both influenza and coronavirus before pregnancy.

In August 2020, the chief infectious disease specialist of the Ministry of Health Vladimir Chulanov said that the Sputnik V vaccine could cause an increase in temperature to 37-37.5 degrees, which should not be shot down. As a last resort, the doctor recommended drinking a paracetamol tablet.

Chulanov added that the drug does not cause a cytokine storm when the immune system reacts dangerously to infection and internal organ damage occurs.

The immunity that we form when the vaccine is administered cannot harm the human body at all, "the infectious disease specialist explained.[42]

Russia will supply the Brazilian state with 50 million doses of Sputnik V vaccine

On September 11, 2020, the Russian Direct Investment Fund (RDIF) announced the conclusion with the health secretariat of the Brazilian state of Bahia of an agreement for the supply of up to 50 million doses of Sputnik V vaccine. The value of the transaction was not disclosed. Read more here.

Presented the results of a clinical study of the Russian vaccine against COVID-19

On September 4, 2020, the Russian Direct Investment Fund (RDIF) and the N.F. Gamaleya National Research Center for Epidemiology and Microbiology announced the publication of the results of clinical trials of the Sputnik V coronavirus vaccine. The corresponding article was published in the medical journal The Lancet.

The article reports that 76 people took part in two stages of vaccine research. In all of them, the drug formed a "stable both humoral and cellular immune response." Side effects "were mostly mild," of which the most common were pain at the injection site, fever to 37-38 ° C, headache, asthenia, muscle and joint pain. According to the article, "no serious side effects were reported during the study." 32 researchers participated in the writing of the material.

As a result of the first two phases of clinical studies, no serious adverse events were detected, in all participants in the studies the vaccine formed a stable immune response. At the same time, the level of antibodies in vaccinated volunteers was 1.4-1.5 times higher than the level of antibodies in people who have had coronavirus.

For comparison: in the British pharmaceutical company AstraZeneca, the level of antibodies in vaccinated volunteers turned out to be approximately equal to the level of antibodies in patients with coronavirus infection. All volunteers developed T-cell immunity, represented by both CD4 + and CD8 + cells. These cells provide recognition and destruction of SARS-CoV-2 infected cells, explained in the RDIF.

The publication in one of the world's most authoritative medical journals The Lancet confirms the high safety and effectiveness of the Russian Sputnik V vaccine and demonstrates the recognition of Russian scientists from the world scientific community. The leadership of the N.F. Gamalei NICEM under the leadership of A.L. Gintsburg and D.Yu. Logunov is confirmed by the outstanding results of their work - advanced vaccine drugs that save a huge number of human lives, - said the head of the RDIF Kirill Dmitriyev.[43]

Start of post-registration trials of a vaccine against COVID-19 with the participation of 40 thousand people

At the end of August 2020, post-registration began in Russia COVID-19 coronavirus vaccine trials. 40 will participate in them thousand people aged 18 and over.

On August 26, 2020, the Ministry of Health announced the issuance of the National Research Center for Epidemiology and Microbiology named after Academician N.F. Gamalei permission to conduct post-registration a clinical trial of the Sputnik V vaccine.

Participation in the study will last six months from the day of vaccination, it will be held on the basis of Moscow medical institutions. For the third phase of testing doctors will select candidates for medical reasons. At Doborovolets must be a Moscow compulsory medical insurance policy, the absence of ARVI in two weeks prior to studies and at the time of vaccination. He should not have the same be transferred to coronavirus infection and contacts with sick COVID-19 at least two weeks before the study.

Research will be held on the basis of centers created in urban polyclinics or polyclinic departments of hospitals. All participants research for six months will be under constant medical supervision. For health monitoring, specialists use telemedicine technologies.

We also created a self-observation diary for residents in a special mobile application. Individual participants will also be given electronic bracelets for measuring blood pressure and body temperature, - said Moscow Mayor Sergei Sobyanina, whose words are quoted on his official portal.

According to the mayor, the study will be funded from city budget. At the end of testing for the product will be issued permanent registration certificate and expanded the range of possible recipients of the vaccine, including the category of people over 60 years old.^[44]

The first vaccine against COVID-19 cost the Russian budget 1.8 billion rubles

At the end of August 2020, it became known that the first vaccine against the coronavirus COVID-19 cost the Russian budget 1.8 billion rubles. This amount was received from the state by the Research Center for Epidemiology and Microbiology named after N.F. Gamalei in the form of subsidies that were intended for the development and production of the drug "Sputnik V."

The costs of the coronavirus vaccine were reported by Vademec, citing documents on state subsidies on the Electronic Budget portal. It follows from them that the Scientific Center named after Gamaleya received 376 million rubles for "experimental scientific developments." But how much money was spent on the development of the vaccine, the document is not indicated. At the end of May 2020, the NRC signed an agreement with the Ministry of Health on subsidies "in order to implement measures to combat the epidemic" for a total of 1.52 billion rubles.

The director of the center, Alexander Gintsburg, said that 1.5 billion rubles are needed for equipment that will allow the production of 4-5 million doses of vaccine per year. The analytical company RNC Pharma said that this was a completely reasonable price, but immediately made a reservation that the very creation of the vaccine could cost no more than 10% of the first subsidy of 376 million rubles. With the allocated money, several full-scale clinical studies could be organized, but the Gamaleya center tested the vaccine on only 38 volunteers.

If there was a ready-made workshop with all communications, then the purchase of equipment for 1.5 billion rubles looks like a completely market story, "Nikolai Bespalov, development director of the analytical company RNC Pharma, told Open Media.

According to him, the Sputnik V vaccine appeared on the basis of the developments already available at the Gamaleya center, so the costs of creating the drug directly could be small, and the most expensive stage is clinical trials. Ошибка цитирования Отсутствует закрывающий тег </ref>^[45]

The new company of Sberbank will be engaged in the production of a vaccine against COVID-19

On August 21, 2020, Sberbank Chairman German Gref announced that a subsidiary of Immunotechnologies LLC was created to produce a vaccine against the coronavirus COVID-19. Read more here.

Start of serial production of vaccine against COVID-19 in the Russian Federation

On August 15, 2020, mass production of the COVID-19 coronavirus vaccine began in Russia. This was reported in the Ministry of Health of the Russian Federation.

The production of a vaccine against a new coronavirus infection has begun, developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of Russia, the ministry said in a statement.

Three enterprises will produce the medicine: Binnopharm, Generium and R-Pharm. At the first stage, 15.5 thousand doses of vaccine were produced.

The head of the Gamaleya Research Center, Alexander Gintsburg, said that the third stage of the study of the Sputnik V vaccine could begin within 7-10 days, after the test protocol is approved by the Ministry of Health.

According to Gintsburg, the third stage of vaccine trials will take place in the Moscow region, since here "there is absolutely all the necessary infrastructure in order to carry out not only vaccination, but also registration."

It will be several tens of thousands of people. Now, since it costs a lot of money, the financial part and so on are being specified, - said the head of the Gamaleya Center.

He also said that the required amount of vaccine will be produced within a year. According to him, three enterprises were able to adapt production to their technology for creating a vaccine.

On August 15, 2020, the head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriyev noted that applications have already been received from more than 20 countries for the purchase of a billion doses of this drug. However, according to him, Russia with the available capacities is capable of producing only 500 million doses of vaccine per year.

The first recipients of the Gamaleya Center vaccine will be health workers and the elderly. The effectiveness of the drug will be assessed based on the results of the formation of population immunity.^[46]

Russian vaccine will protect against COVID-19 for at least 2 years after administration

On August 13, 2020, it became known that the Russian vaccine will protect against coronavirus at least two years after administration.Russia Gamaleya National Research Center (NRC) for Epidemiology and Microbiology Director Alexander Gintsburg told about this on the air of the TV channel "1."

We assume that we guarantee, by analogy with other vaccines created on this platform, that the duration of this vaccine, its protective properties will not last for a short period, six months or a year, but for at least two years, "Gunzburg said.

According to him, the introduction of the first component of the vaccine will ensure the production of antibodies neutralizing the COVID-19-causing coronavirus, and the introduction of the second will increase the number of antibodies and, in addition, will allow multiplying the so-called "memory cells that can protect a person from the virus after a long time, when the number of primary antibodies will decrease.

Gunzburg also noted that the domestic vaccine drug is completely safe and was registered in accordance with all the norms and rules of the law. The Russian vaccine against coronavirus differs from its foreign counterparts in that it is two-component, Gunzburg said.

Our final product differs from those products that are now being created in the countries I have listed, in that we have a two-component vaccine, he said.

Earlier, the Ministry of Health said that immunity to coronavirus can persist up to two years after the introduction of the vaccine. As noted in the department, the vaccine does not contain COVID-19 components, a double administration scheme allows you to form a long-term immunity.

Doctors and teachers will be the first to receive the vaccine. It will be available to citizens from January 1, 2021. The drug will be made free. When sold abroad, the vaccine will cost at least $10 per two doses.^[47]

Plan for launching the production of the Binnopharm Group vaccine in Zelenograd

On August 11, 2020, Sistema announced to Zdrav.Expert that the world's first vaccine for the prevention of coronavirus infection has been registered. The vaccine was developed by the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya "(hereinafter -" N.F. Gamaleya National Research Center "). The only site for the production of vaccines in Russia, in addition to the N.F. Gamalei, in the registration certificate, is indicated the Binnopharm Group pharmaceutical plant in Zelenograd. Read more here.

Registration of the world's first coronavirus vaccine

On August 11, 2020 AFK Sistema , it announced Zdrav.Expert that the first in the world was registered vaccine to prevent coronavirus infection. A vaccine has been developed. "National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya" (hereinafter - "N.F. Gamaleya National Research Center for Epidemiology and Microbiology") The only platform for the production of the vaccine in, in addition to Russia the N.F. Gamaleya, in the registration certificate is indicated in the AFK Sistema "Plant" Group pharmaceutical.Binnopharm Zelenograd

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The early production of a vaccine for the prevention of COVID-19 is one of the most pressing tasks in the fight against the pandemic. We are pleased that our pharmaceutical plant in Zelenograd, which has experience in the production of vaccines and biotechnics, is participating in this project. The capacity of the Binnopharm plant allows for August 2020 to produce about 1.5 million doses of vaccine per year. We plan to equip the plant with additional equipment, which will increase the volume of vaccine production. First of all, Russian doctors can be provided with vaccines, who, being at the forefront of the fight against coronavirus, are the main risk group. The first batches of the vaccine are already ready to be sent to the regions of Russia, "said Vladimir Chirakhov, President of AFK Sistema.

The peculiarity of the vaccine is to reduce the time for the development of immunity to the virus. According to the N.F. Gamalei, during the first vaccination, humoral cell immunity is produced, and after the second, memory cells are formed - one of the main properties of the vaccine. Clinical trials of the vaccine began in June 2020. Mass production of the vaccine is planned to be launched by the end of 2020.

"NICEM named after N.F. Gamalei" was one of the first not only in Russia, but also in the world to complete preclinical studies of an experimental sample of a vaccine against coronavirus. The results of clinical studies confirmed the efficacy and safety of the drug.

Completion of the development of the first Russian vaccine against COVID-19

On July 21, 2020, First Deputy Head of the Ministry of Defense Ruslan Tsalikov announced the readiness of the first Russian vaccine against the coronavirus COVID-19. Specialists of the Ministry of Defense, doctors of the Burdenko Hospital and scientists of the Gamaleya Research Center worked on it.

Final assessments of the test results by our specialists and scientists of the Gamaleya National Research Center have already been made. At the time of discharge, all volunteers, without exception, having received immunity to coronavirus, felt fine. Thus, the first domestic vaccine against a new coronavirus infection is ready, - said Tsalikov in a conversation with "Arguments and Facts."

According to the head of the Department of Microbiology, Virology and Immunology of the Sechenov First Moscow State Medical University, Academician of the Russian Academy of Sciences Vitaly Zverev, the Russian vaccine is not yet ready for widespread use, because in such a short time they simply could not carry out all the necessary tests.

These are not trials, but profanation, because they cannot take only a few months. The vaccine is administered to healthy people and there are certain stages of clinical trials that cannot be reduced. Moreover, we are not talking about some kind of terrible deadly disease, after all, we understand that the coronavirus is not such a terrible infection, so there is no need to rush into this, "he said in an interview with the Vzglyad newspaper.

The fact that military personnel participate in clinical trials negatively affects confidence in the vaccine and its data, says Anton Gopka, general partner and co-founder of ATEM Capital. Detailed data on the number and class of side effects, as well as information on the cellular and humoral immune response to the vaccine, should be disclosed, and a study of the clinical effectiveness of the vaccine in the second phase should take place, adds Gopka.^[48]

Named the fee of volunteers who tested the first vaccine against coronavirus in Russia

On July 15, 2020, the fee of volunteers who tested the first vaccine against the coronavirus COVID-19 in Russia became known. They will receive 100 thousand rubles each, said one of the volunteers Anna Kutina at a press conference on Wednesday.

She noted that after the introduction of the vaccine, she had a temperature of 38 degrees for two days, but she was confused with paracetamol. Another volunteer Natalya Ageeva said that she had minor pain after the vaccine was administered, but without a temperature, Interfax reports.

The third participant in the tests, Georgy Smirnov, added that his head began to hurt in the evening, a temperature of 37.5 degrees appeared in the morning, it was shot down, and there was also a seal at the place of vaccine administration.

According to Elena Smolyarchuk, head of the Center for Clinical Study of Medicines at Sechenov University, the volunteers transferred the vaccine "absolutely well." Due to the fact that the test participants were in isolation, psychologists and coaches worked with them - "so that they came out not only the first to receive the vaccine, but also in good physical shape."

Sergey Semitko, director of the Scientific and Practical Center for Interventional Cardioangiology at Sechenov University, also said that the tolerability of the vaccine "was good."

Registration of a vaccine against the new coronavirus may occur if there are positive results on the fact of the first phase of tests, Smolyarchuk said.

The COVID-19 coronavirus vaccine will go into civilian circulation on August 14-15, said Alexander Gintsburg, director of the Gamaleya Center for Epidemiology and Microbiology. According to him, the civil circulation of vaccines will be allowed on conditions that are actually the third phase. Those who were given the vaccine will be monitored. If side effects appear, the Ministry of Health has the right to revoke the permit, Gunzburg said.^[49]

World's first coronavirus vaccine tested in Russia

On July 12, 2020, Vadim Tarasov, director of the Institute of Translational Medicine and Biotechnology, announced the successful completion of trials, according to him, of the world's first vaccine against the coronavirus COVID-19. Testing was carried out by Sechenov University, and the vaccine itself was developed by specialists from the N.F. Gamaleya National Research Center for Epidemiology and Microbiology.

Sechenov University in the context of a pandemic situation acted not only as an educational institution, as is customary, but also as a scientific and technological center that is able to participate in the creation of such important and complex products as drugs... We worked with this vaccine, starting with preclinical studies and the development of the protocol, and we are now conducting clinical studies, "Tarasov said in a conversation with RIA Novosti.

The task of this stage of the study was to show the safety of the vaccine for health, Alexander Lukashev, director of the Institute of Medical Parasitology, Tropical and Vector-borne Diseases of Sechenov University, told the agency. The safety of the vaccine has been confirmed. It corresponds to the safety of those vaccines that are now present on the market, he said.

According to Lukashev, the volunteers participating in the vaccine trials were divided into two groups: the first received one dose of the vaccine, and the second - two, he said. Neither were found to have negative reactions other than fever in the early days. The discharge is scheduled for July 15 and 20, 2020, after which their condition will be monitored to assess how their immunity behaves, he said.

Tarasov explained that the volunteers were in isolation for a long time, were limited in contacts with the outside world even before the start of the tests in order to exclude infection with the coronavirus.^[50]

Headache and high fever. How is the first vaccination of Russians against COVID-19

On June 23, 2020, it became known about the reaction of the body of the first volunteers to the COVID-19 coronavirus vaccine. 18 people received the drug on June 18, the press service of the First Moscow State Medical University named after I.M. Sechenov.

In the first hours, some of them had minimal post-vaccination reactions - a slight increase in temperature, headache, etc., which were independently stopped during the day, the university said.

According to Elena Smolyarchuk, director of the Center for Clinical Study of Medicines at Sechenov University , the reaction to vaccination in people was standard, and by June 23 all study participants were doing well.

On June 23, 2020, the second group of volunteers in the amount of 20 people received an injection of the drug at the Scientific and Practical Center for Interventional Cardioangiology, which is part of the structure of the clinical center of the university.

Volunteers live in single and double wards of the Scientific and Practical Center for Interventional Cardioangiology. Researchers are constantly in touch with people, if necessary, psychological support is provided.

Also, in order to avoid hypodynamics, a course of physiotherapy exercises began, which are conducted by employees of the Department of Sports Medicine and Medical Rehabilitation of Sechenov University. This will allow you to maintain physical activity and not gain excess weight. Due to the sedentary lifestyle, some muscles may atrophy, joint diseases may worsen, hypertension may increase, and it is movement that is the method of preventing hypertension, the Sechenov University reported.

The group of volunteers includes men and women aged 18 to 65 years.^[51]

Start of clinical trials

On June 17, 2020 Ministry of Health Russia , he announced the start of clinical trials of the coronavirus vaccine. COVID-19 The tests will be conducted on two groups of volunteers of 38 people each.

Two forms of the vaccine were developed by the N.F. Gamalea National Research Center for Epidemiology and Microbiology (NITSEM). In the Burdenko military hospital , a liquid vaccine intended for intramuscular administration will be tested, and at Sechenov University - a vaccine in the form of a powder, from which a solution for administration to the muscle will be prepared on the spot.

As reported on the agency's website, the key point is voluntary participation in research. Participants were provided with all information about the procedure, possible benefit, risks and inconvenience regarding participation in the study. The volunteer will be able to discuss the issue of participation in the study with a research doctor, as well as ask questions of interest.

After vaccination, volunteers will stay 28 days in isolation in a hospital. Doctors will monitor their health, take blood tests, including to assess the immunogenicity of the vaccine, and monitor the absence of adverse reactions to the vaccine. They will also monitor the formation of the body's immune response in various respects. After discharge from the hospital, research doctors will monitor the health of volunteers for six months. 15.9 million rubles will be spent on the study of the vaccine and its testing.

As it became known in mid-June 2020, another Russian vaccine developed by the Vector Scientific Center will be tested in humans in a month. According to the general director of the enterprise Rinat Maksyutov, the drug may be registered in the fall.^[52]

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